BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK SUTURE 30"(75CM) 0 BLK

    MDR report key: 9285663 · Received November 6, 2019

    Report

    Report Number
    2210968-2019-89607
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044418
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT MAH862, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. PLEASE PROVIDE SPECIFIC NUMBER OF DEVICES WITH SUTURE BREAKAGE ISSUE DURING USE IN THE PROCEDURE. HOW WAS THE CASE COMPLETED? HAS THE PRODUCT BEEN RETURNED YET? NOTE: EVENTS REPORTED IN 2210968-2019-89605, AND 2210968-2019-89606.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING WHEN TYING OFF OR SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082919 SILK SUTURE 30"(75CM) 0 BLK SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. MAH862 10705031044418

    Patients

    Seq Age Sex Outcome Treatment
    1